The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).
Endotronix, the creators of the Cordella Sensor, work to advance treatment of heart failure.
"We are excited to begin enrollment in this groundbreaking trial that will provide the highest level of clinical evidence to redefine the standard of care for patients suffering from chronic heart failure," said Dr. Katrin Leadley, chief medical officer of Endotronix. "The trial design and treatment guidelines aim to proactively lower patient PA pressures and enable physicians to maintain target pressures, which we believe will decrease patient mortality and lower the rate of HF-related hospitalizations."
The Cordella Sensor will be fully integrated into the Cordella heart failure system. This system allows patients to share data with health care providers from the comfort of their own homes.
"This is a pivotal milestone for both the company and patients suffering from heart failure, " said Harry Rowland, CEO of Endotronix. “PROACTIVE-HF is designed to show a definitive benefit for PA pressure-guided management and provide the data required for reimbursement of the implantable Cordella Sensor across the U.S. This study, along with our recently initiated CE Mark trial, SIRONA II, will build a solid clinical foundation for market adoption of the Cordella Sensor and Cordella System."
The study will begin registering participants in the third quarter of 2019.
